Trial Evaluating Three Fixed Dosages of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With Schizophrenia

• Status: Completed
• Trial end date: 2005-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the double blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (6, 9, and 12 mg/day) compared with placebo in adult patients with schizophrenia.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Olanzapine; Paliperidone Palmitate

Criteria

Inclusion Criteria:

• Double-blind phase: DSM-IV diagnosis of schizophrenia at least 1 year prior to screening

• experiencing an acute episode, with a total PANSS score at screening between 70 and 120

• agree to voluntary hospitalization for a minimum of 14 days

• willing and able to fill out self-administered questionnaires

• able to be compliant with self-administration of medication, or have consistent help/support available.

Open-label extension phase: completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy

• patient and investigator agree that open-label treatment is in the best interest of the patient.

Exclusion Criteria:

• Double-blind phase: DSM-IV axis I diagnosis other than schizophrenia

• DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)

• history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)

• history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)

• previous history of lack of response (2 adequate trials) to any antipsychotic

• significant risk of suicidal or violent behavior. Open-label phase: At significant risk for suicidal or violent behavior

• received an injection of a depot antipsychotic since entry into the preceding double-blind phase.